Threaded suture anchor

ABSTRACT

The present disclosure relates to a suture anchor. The suture anchor includes a body having a proximal end and a distal end, the body including threads along at least a partial length of the body and at least one through hole, the threads including a profile such that the threads located near the distal end of the body include a first shape and the threads located near the proximal end of the body include a second shape different from the first shape. Delivery devices and anchor dilators are also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Patent Application No.61/255,508, filed Oct. 28, 2009, U.S. Patent Application No. 61/255,509,filed Oct. 28, 2009, U.S. Patent Application No. 61/255,510, filed Oct.28, 2009, U.S. Patent Application No. 61/255,511, filed Oct. 28, 2009,U.S. Patent Application No. 61/297,418, filed Jan. 22, 2010, U.S. PatentApplication No. 61/309,643, filed Mar. 2, 2010, U.S. Patent ApplicationNo. 61/307,980, filed Feb. 25, 2010, U.S. Patent Application No.61/311,841, filed Mar. 9, 2010, U.S. Patent Application No. 61/324,966,Apr. 16, 2010, and U.S. Patent Application No. 61/359,084, filed Jun.28, 2010, the disclosures of which are incorporated herein by referencein their entireties.

BACKGROUND Field of Technology

The present disclosure relates to the repair of soft tissue and,specifically, devices for use in such repair.

Related Art

Arthroscopic procedures often require soft tissue to be reattached tobone. To achieve this, anchors are placed in the bone and suturesattached to the anchor are passed through the tissue to securely retainthe tissue in place. When making a repair of soft tissue to bone, it isadvantageous for the suture anchor and the anchor inserter to havefeatures that allow for ease of insertion and increased fixation of theanchor to the bone. A procedure, and devices for use in such procedure,that securely attaches tissue to bone is needed.

SUMMARY

In an aspect, the present disclosure relates to a suture anchor. Thesuture anchor includes a body having a proximal end and a distal end,the body including threads along at least a partial length of the bodyand at least one through hole, the threads including a profile such thatthe threads located near the distal end of the body include a firstshape and the threads located near the proximal end of the body includea second shape different from the first shape.

In another aspect, the present disclosure relates to a delivery device.The device includes a square-shaped end including two prongs extendingfrom the end, the prongs located at opposite corners of the end, whereinthe device is cannulated.

In yet another aspect, the present disclosure relates to a deliverydevice. The device includes an end having a first area and a secondarea, wherein the first area is of a first shape and the second area isof a second shape different from the first shape, the first shape andthe second shape including different diameters, the device beingcannulated.

In a further aspect, the present disclosure relates to a deliverydevice. The device includes an end having a first area and a secondarea, wherein the first area is of a first shape and the second area isof a second shape different from the first shape, the first shape andthe second shape including different diameters, the device beingcannulated, wherein one of the areas includes tangs extending outwardlyfrom the device.

In yet a further aspect, the present disclosure relates to an anchordilator. The dilator includes a handle; a shaft coupled to the handle;and a dilating portion coupled a distal end of the shaft, the dilatingportion including a body having threads, the threads including a profilesuch that the threads located near the distal end of the body include afirst shape and the threads located near the proximal end of the bodyinclude a second shape different from the first shape.

In an aspect, the present disclosure relates to an anchor dilator. Theanchor dilator includes a handle; a shaft coupled to the handle; and adilating portion coupled to a distal end of the shaft, the dilatingportion including a body having a threaded first portion and anon-threaded second portion, the threaded first portion including aprofile such that threads located near a distal end of the body includea first shape and threads located near a proximal end of the bodyinclude a second shape different from the first shape.

Further areas of applicability of the present disclosure will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the preferred embodiment of the disclosure, are intended forpurposes of illustration only and are not intended to limit the scope ofthe disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and form a part ofthe specification, illustrate the embodiments of the present disclosureand together with the written description serve to explain theprinciples, characteristics, and features of the disclosure. In thedrawings:

FIG. 1 shows an isometric view of the suture anchor of the presentdisclosure without suture.

FIG. 2 shows a side elevational view of the suture anchor of FIG. 1 withsuture.

FIG. 3 shows a cross-sectional view of the suture anchor of FIG. 1.

FIG. 4 shows a top view of the suture anchor of FIG. 1.

FIG. 5 shows an isometric view of a distal end of the suture anchorinserter of the present disclosure.

FIG. 6 shows a cross-sectional view of the suture anchor assembly of thepresent disclosure without suture.

FIG. 7 shows a side elevational view of the of the suture anchorassembly of FIG. 6 with suture.

FIGS. 8-9 show a method of soft tissue repair using the suture anchorand suture anchor assembly of FIGS. 1 and 7.

FIGS. 10A and 10B show a side view and an isometric view of analternative embodiment of the suture anchor of the present disclosure.

FIG. 11 shows a cross-sectional view of the suture anchor of FIG. 10.

FIG. 12 shows a top view of the suture anchor of FIG. 10.

FIG. 13 shows a side view of another alternative embodiment of thesuture anchor of the present disclosure.

FIG. 14 shows a cross-sectional view of the suture anchor of FIG. 13.

FIG. 15 shows a side view of the suture anchor of FIG. 13 and a deliverydevice coupled to the suture anchor.

FIG. 16 shows a cross-sectional view of the suture anchor-deliverydevice of FIG. 15.

FIG. 17 shows an isometric view of a distal end of the delivery deviceof FIG. 15.

FIG. 18 shows a side view of yet another alternative embodiment of thesuture anchor of the present disclosure.

FIG. 19 shows a cross-sectional view of the suture anchor of FIG. 18.

FIG. 20 shows an isometric view of the suture anchor of FIG. 18.

FIG. 21 shows an isometric view of the suture anchor of FIG. 18 and adelivery device coupled to the anchor.

FIG. 22 shows a cross-sectional view of the suture anchor-deliverydevice of FIG. 21.

FIG. 23 shows an isometric view of the distal end of the delivery deviceof FIG. 21.

FIG. 24 shows a side view of an anchor dilator for use with the sutureanchors of the present disclosure during tissue repair.

FIG. 25 shows a side view of the distal end of the anchor dilator ofFIG. 24.

FIG. 26 shows a side view of an alternative embodiment of the anchordilator of the present disclosure.

FIG. 27 shows an enlarged view of the distal end of the anchor dilatorof FIG. 26.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following description of the preferred embodiment(s) is merelyexemplary in nature and is in no way intended to limit the disclosure,its application, or uses.

FIGS. 1-4 show the threaded suture anchor 10 of the present disclosure.The anchor 10 includes a body 11 having a proximal end 12 and a distalend 13. The body 11 is tapered from the proximal end 12 to the distalend 13 such that the distal end 13 is pointed. The anchor 10 is threadedalong at least a partial length of the body 11 such that a portion ofthe distal end 13 is not threaded. The threads 14 have a profile suchthat the threads 14 a at the distal end 13 have a sharper, cutting shapeand the threads 14 b at the proximal end 12 have a square shape. Thepurpose for this transitional thread profile will be further describedbelow. The anchor 10 also includes two through holes 15,16 and a bridge17 located between the holes 15,16. The bridge 17 is of a size thatinterrupts the least number of threads 14.

As shown more clearly in FIGS. 3 and 4, the anchor 10 also includes acannulation 18. The cannulation 18 has a square shape such that at leasttwo of its corners 18 a are aligned with through holes 15,16 and two ofits corners 18 b are not aligned with through holes 15,16, as shown moreclearly in FIG. 4. The cannulation 18 extends though the anchor 10 suchthat a portion of the cannulation 18 extends around through hole 15 toform slots 18 c that will be used to house a portion of the anchorinserter, as will be further described below. The slots 18 c are alignedwith corners 18 b of the cannulation.

As shown in FIG. 2, a flexible member 19, such as a suture, extendsaround the bridge 17 and through the cannulation 18, via the corners 18a of the cannulation 18 that are aligned with the through holes 15,16.

FIG. 5 shows a distal end 21 of the anchor inserter 20. The end 21 issquare-shaped to correspond with the square-shaped cannulation 18 whenthe end 21 is housed within the cannulation 18, as shown in FIGS. 6 and7. Additionally, two prongs 22 extend from the distal end 21. These twoprongs 22 are configured for housing in the slots 18 c of thecannulation 18, as more clearly shown in FIG. 6. Housing of the prongs22 in the slots 18 c provides the inserter 20 with a higher insertiontorque during advancement of the anchor 10 into bone, as will be furtherdescribed below. The anchor inserter 20 is cannulated such that when theend 21 is housed within the cannulation 18, the suture 19 extendsthrough the cannulation 23 of the inserter 20. The corners 18 a maximizethe cross-sectional area available for the suture 19 to pass throughfrom the bridge 17 and up through the driver cannulation 23.

FIGS. 8 and 9 show the suture anchor assembly 50 (anchor 10 and inserter20) of the present disclosure during use in the repair of tissue. Theanchor 10 is inserted into a previously drilled hole in the bone 30 androtated until the entire anchor 10 is located in the bone 30, as shownin FIG. 8. During initial insertion of the anchor 10, the cuttingthreads 14 a help ease introduction of the anchor 10 into the bone bycutting through the bone 30. As rotation of the anchor 10 continues andthe thread profile begins to change from the cutting threads 14 a to thesquare-shaped threads 14 b, an increased amount of interference occursbetween the threads 14 and the bone 30, which causes an increase intorsion resistance. This increase in torsion resistance allows theanchor 10 to be firmly affixed in the bone 30 and substantially reducesthe possibility of the anchor 10 from backing out of the bone 30.

Once the anchor 10 has been inserted into the bone 30, the inserter 20is removed from the anchor 10 and soft tissue 40 is placed adjacent tothe anchor 10, as shown more clearly in FIG. 9. Ends 19 a,19 b of thesuture 19 are inserted through the soft tissue 40 and tied to fixate thetissue 40 to the bone.

FIGS. 10A and 10B show alternative embodiments of the suture anchor 60of the present disclosure. Suture anchor 60 is similar to suture anchor10 except suture anchor 60 doesn't include two through holes. Rather,suture anchor 60 includes only one through hole 66. Having a singlethrough hole allows for even less interruption of the number of threads64. As shown more clearly in FIGS. 11 and 12, similar to anchor 10,anchor 60 also includes a cannulation 68 having a square shape such thatat least two of its corners 68 a are aligned with through hole 66 andtwo of its corners 68 b are not aligned with through hole 66, as shownmore clearly in FIG. 12. The cannulation 68 extends though the anchor 60such that a portion of the cannulation 68 extends around the bridge 67to form slots 68 c that will be used to house a portion of the anchorinserter, as described above. The slots 68 c are aligned with corners 68b of the cannulation.

As shown in FIGS. 10A and 10B, a flexible member 69, such as a suture,extends around the bridge 67 and through the cannulation 68, via thecorners 68 a of the cannulation 68 that are aligned with the throughhole 66. The anchor inserter 20 of FIG. 5 is used to insert the anchor60 into bone during tissue repair, similar to the manner in which theinserter 20 is used with suture anchor 10, as described above.

Other alternative features/embodiments are also within the scope of thisdisclosure. The distal ends of the anchors in FIGS. 1-10 may be fullythreaded. The thread shapes at the proximal ends of the anchors may beany shape that would allow for an increased amount of interferencebetween the threads and the bone. The number of through holes may beless or more than two and they may be located anywhere along the lengthsof the anchors. The cannulations of the anchors may be of any shapesthat would maximize the cross-sectional areas available for the suturesto pass through from the bridges and up through the driver cannulation.The number of sutures housed within each anchor may be more than one. Inaddition, flexible members other than sutures may be used.

The distal end of the inserter may include more or less than two prongs.Additionally, it is within the scope of this disclosure to have a distalend with prongs that do not straddle a through hole. The shape of thedistal end of the driver may be other than square and therefore havemore or less than four sides. The anchors are made from a non-metalmaterial via an injection molding process. However, other material,which would allow the anchors to withstand the forces applied duringsurgery, and other processes may be used. Also, the driver is made froma metal material. However, other material that would allow the driver towithstand the forces applied during surgery may be used. Rather thandrilling pilot holes into the bone and then inserting the anchors intothe bone via the holes, the anchors may be inserted by tapping on theend of the inserter to advance the pointed distal ends of the anchorsinto the bone and then rotating the inserter to advance the rest of theanchors. Also, rather than tying the ends of the sutures to fixate thetissue, the tissue may be fixated to bone in another manner, such as bypassing the ends through a second anchor and then placing the secondanchor into the bone at another location.

FIGS. 13 and 14 show another alternative embodiment of the suture anchor70 of the present disclosure. The anchor 70 includes a body 71 having aproximal end 72 and a distal end 73. The body 71 is tapered from theproximal end 72 to the distal end 73 such that the distal end 73 ispointed. Unlike the earlier embodiments, the distal end 73 isspecifically designed to allow for insertion of the anchor 70 into bonewithout first creating a hole in the bone, as will be further describedbelow. Similar to the earlier embodiments, the anchor 70 is threadedalong at least a partial length of the body 71 such that a portion ofthe distal end 73 is not threaded. The threads 74 have a profile suchthat the threads 74 a at the distal end 73 have a sharper, cutting shapeand the threads 74 b at the proximal end 72 have a square shape. Theanchor 70 also includes two through holes 75,76 and a bridge 77 locatedbetween the holes 75,76. The bridge 77 is of a size that interrupts theleast number of threads 74.

As shown more clearly in FIG. 14, the anchor 70 also includes acannulation 78. The cannulation 78 includes two areas 78 a,78 b. Area 78a has a square shape and area 78 b has a rounded or circular shape.Additionally, area 78 a has a larger diameter than area 78 b. The areas78 a,78 b are designed to correspond to the design of the deliverydevice used to insert the anchor 70 into bone. For instance, FIG. 17shows a distal end 81 of the delivery device 80 used to insert anchor 70into bone. Similar to areas 78 a,78 b, the distal end 81 has asquare-shaped area 81 a and a rounded or circular-shaped area 81 b. Alsosimilar to areas 78 a,78 b, area 81 a has a larger diameter than area 81b. As shown in FIG. 16, once the distal end 81 is inserted intocannulation 78, the shape of area 78 a corresponds with the shape ofarea 81 a and the shape of area 78 b corresponds with the shape of area81 b. The shapes of the areas 78 a,78 b,81 a,81 b correspond with eachother to allow for the proper amount of torque to be applied to theanchor 70 while the anchor 70 is being inserted into bone, as will befurther described below.

FIGS. 18-20 show yet another alternative embodiment of the suture anchor90 of the present disclosure. Suture anchor 90 includes a body 91 havinga proximal end 92 and a distal end 93. The body 91 is tapered from theproximal end 92 to the distal end 93 such that the distal end 93 ispointed. Similar to anchor 70, the distal end 93 is specificallydesigned to allow for insertion of the anchor 90 into bone without firstcreating a hole in the bone, as will be further described below. Alsosimilar to the earlier embodiments, the anchor 90 is threaded along atleast a partial length of the body 91 such that a portion of the distalend 93 is not threaded. The threads 94 have a profile such that thethreads 94 a at the distal end 93 have a sharper, cutting shape and thethreads 94 b at the proximal end 92 have a square shape. The anchor 90also includes two through holes 95,96 and a bridge 97 located betweenthe holes 95,96. The bridge 97 is of a size that interrupts the leastnumber of threads 94. Additionally, as shown in FIG. 20, anchor 90includes grooves 98, for purposes to be described later.

As shown more clearly in FIG. 19 and similar to anchor 70, the anchor 90also includes a cannulation 99. The cannulation 99 includes two areas 99a,99 b. Area 99 a has a square shape and area 99 b has a rounded orcircular shape. Additionally, area 99 a has a larger diameter than area99 b. The areas 99 a,99 b are designed to correspond to the design ofthe delivery device used to insert the anchor 90 into bone. Forinstance, FIG. 23 shows a distal end 101 of the delivery device 100 usedto insert anchor 90 into bone. Similar to areas 99 a,99 b, the distalend 101 has a square-shaped area 101 a and a rounded or circular-shapedarea 101 b. Also similar to areas 99 a,99 b, area 101 a has a largerdiameter than area 101 b. Furthermore, the device 100 includes tangs 102extending outwardly from the device 100. As shown in FIGS. 21 and 22,once the distal end 101 is inserted into cannulation 99, the shape ofarea 99 a corresponds with the shape of area 101 a and the shape of area99 b corresponds with the shape of area 101 b. Also, the tangs 102 fitwithin the grooves 98. The shapes of the areas 99 a,99 b,101 a,101 bcorrespond with each other and the tangs 102 fit within the grooves 98to allow for the proper amount of torque to be applied to the anchor 90while the anchor 90 is being inserted into bone, as will be furtherdescribed below.

As shown in FIGS. 15 and 21, flexible members 110,120, such as a suture,extend around the bridges 77,97 of the anchors 70,90 and through thecannulations 83,103 of the delivery devices 80,100.

Prior to insertion of any of anchors 10,60,70,90, the anchor dilator 200may be used to prep the bone for insertion of the anchor 10,60,70,90.The dilator 200 includes a shaft 201, a handle 202 coupled to a proximalportion 201 a of the shaft 201, and a dilating portion 203 coupled to adistal portion 201 b of the shaft 201. The dilating portion 203 has abody 203 a similar to the body 71,91 of each of anchors 70,90 and athread profile similar to the thread profile of anchors 10,60,70,90.During tissue repair, a hole is made in bone by inserting the dilatingportion 203 into the bone in an axial and rotational motion such thatthe user may strike the handle 202 to insert the pointed distal end 203b and then rotate the dilator 200 to insert the rest of the dilatingportion 203. The dilating portion 203 is then removed from the bone andone of the anchors 10,60 may be inserted into the hole similar to themethod described above for FIGS. 8 and 9 or one of the anchors 70,90 maybe inserted into the hole in a manner similar to the manner of insertingthe dilating portion of the anchor dilator, as described above. Afterinsertion of one of the anchors 10,60,70,90 into the hole, tissue repairis completed in a manner similar to the method described above for FIGS.8 and 9.

Similar to anchor dilator 200, anchor dilator 300, shown in FIGS. 26 and27, may be used to prep the bone for insertion of the anchor10,60,70,90. The dilator 300 includes a shaft 301, a handle 302 coupledto a proximal portion 301 a of the shaft 301, and a dilating portion 303coupled to a distal portion 301 b of the shaft 301. The dilating portion303 has a body 303 a having a threaded first portion 303 b and anon-threaded second portion 303 c. The threaded first portion 303 b hasa thread profile similar to the thread profile of anchors 10,60,70,90.During tissue repair, a hole is made in bone by axially inserting thenon-threaded second portion 303 c into bone, via tapping of the handle302, until the entire second portion 303 c is inserted into the bone.The user then rotates the handle 302 to insert the entire first portioninto the bone. The dilating portion 303 is then removed from the boneand one of the anchors 10,60,70,90 may be inserted into the hole. Afterinsertion of one of the anchors 10,60,70,90 into the hole, tissue repairis completed in a manner similar to the method described above for FIGS.8 and 9.

For the purposes of this disclosure, anchors 70,90 are made from a metalmaterial, such as titanium. However, other materials could be used tomake each of the anchors 10,60,70,90. Anchors 70,90 and their featuresmay be formed from a machining process or other known processes. Thedelivery devices 80,100 are made from a metal material via a machiningprocess or other known process. The devices 80,100 may be made fromanother material that would allow the devices 80,100 to withstand theforces applied to the devices 80,100 during insertion of the anchors10,60,70,90. The anchor dilator 200,300 is made from a metal material,however, other materials that would allow the dilator 200,300 towithstand the forces applied to the dilator 200,300 during insertion ofportion 203,303 into bone may be used. The dilator 200,300 may be madefrom a machining process or other known process. The delivery devices20,80,100 include handles opposite the distal ends 21,81,101 of thedevices 20,80,100.

As various modifications could be made to the exemplary embodiments, asdescribed above with reference to the corresponding illustrations,without departing from the scope of the disclosure, it is intended thatall matter contained in the foregoing description and shown in theaccompanying drawings shall be interpreted as illustrative rather thanlimiting. Thus, the breadth and scope of the present disclosure shouldnot be limited by any of the above-described exemplary embodiments, butshould be defined only in accordance with the following claims appendedhereto and their equivalents.

1-6. (canceled)
 7. A anchor comprising: a body including a proximal end,a distal end, and a longitudinal axis extending between the proximal anddistal ends, the body including threads extending along at least apartial length of the body such that a portion of the distal end is notthreaded, the body defining a cannulation extending along thelongitudinal axis configured to receive an inserter; a first throughhole and a second through hole oriented transverse to the longitudinalaxis of the body, the second through hole being distal to the firstthrough hole along the longitudinal axis, each of the through holesconfigured to receive at least one suture; and a suture bridge formedwithin the body and extending between the first through hole and thesecond through hole; wherein a profile of the threads located near thedistal end of the body has a first shape and a profile of the threadslocated near the proximal end of the body has a second shape differentfrom the first shape.
 8. The anchor of claim 7, wherein the threadstransition from the first shape to the second shape.
 9. The anchor ofclaim 7, wherein the first shape is sharp for cutting into bone and thesecond shape is blunt for producing interference between the threads andbone.
 10. The anchor of claim 7, wherein the threads extend from theproximal end of the body to an area distal to the second through hole.11. The anchor of claim 7, wherein the cannulation has a first area anda second area, the second area being distal to the first area, a sizeand shape of the first area being different than a size and shape of thesecond area.
 12. The anchor of claim 11, wherein the shape of the firstarea is a polygonal shape and the shape of the second area is a circularshape.
 13. The anchor of claim 11, wherein a diameter of the first areais selected to be larger than a diameter of the second area.
 14. Theanchor of claim 7, wherein the distal end of the body is tapered todefine a point configured to allow for insertion of the anchor into bonewithout creating a bone hole prior to the insertion.
 15. The anchor ofclaim 7, wherein a size of the bridge is selected to interrupt the leastnumber of threads extending along the body adjacent to the first andsecond through holes.
 16. A delivery device and anchor combination, thecombination comprising: a delivery device comprising an elongate shafthaving a proximal end, a distal end, and a longitudinal cannulationextending between the proximal end and the distal end, a size and shapeof the distal end of the shaft being different than a size and shape ofthe proximal end of the shaft; and an anchor comprising: a bodyincluding a proximal end, a tapered distal end, and a longitudinal axisextending between the proximal and distal ends, the body includingthreads extending along at least a partial length of the body such thata portion of the distal end is not threaded, the body defining acannulation extending along the longitudinal axis configured to receivean inserter; a first through hole and a second through hole orientedtransverse to the longitudinal axis of the body, the second through holebeing distal to the first through hole along the longitudinal axis, eachof the through holes configured to receive at least one suture; a suturebridge formed within the body and extending between the first throughhole and the second through hole; wherein the cannulation of the anchorbody has a first area and a second area, the second area being distal tothe first area, a size and shape of the first area being different thana size and shape of the second area, and wherein the size and shape ofthe first area of the cannulation is selected to correspond to the sizeand shape of the proximal end of the shaft, and the size and shape ofthe second area of the cannulation is selected to correspond to the sizeand shape of the distal end of the shaft.
 17. The combination of claim16, wherein the anchor is positioned on the shaft such that the proximalend of the shaft engages the first area of the cannulation of the anchorbody and the distal end of the shaft engages the second area of thecannulation of the anchor body.
 18. The combination of claim 16, whereinthe shape of the first area of the cannulation of the anchor body is apolygonal shape and the shape of the second area of the cannulation ofthe anchor body is a circular shape.
 19. The combination of claim 16,wherein the shape of the proximal end of the shaft is a polygonal shapeand the shape of the distal end of the shaft is a circular shape. 20.The combination of claim 16, wherein a diameter of the first area of thecannulation of the anchor body is selected to be larger than a diameterof the second area of the cannulation of the anchor body.
 21. Thecombination of claim 16, wherein a diameter of the proximal end of theshaft is selected to be larger than a diameter of the distal end of theshaft.
 22. The combination of claim 16, wherein a profile of the threadslocated near the distal end of the body has a first shape and a profileof the threads located near the proximal end of the body has a secondshape different from the first shape.
 23. The combination of claim 16,wherein the threads transition from the first shape to the second shape.24. The combination of claim 16, wherein the first shape of the threadsis sharp for cutting into bone and the second shape of the threads isblunt for producing interference between the threads and bone.
 25. Thecombination of claim 16, further comprising a flexible member extendingaround the bridge of the anchor and through the cannulation of thedelivery device.